RecruitingNot Applicable

Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants.

Italy71 participantsStarted 2022-05-20

Plain-language summary

The goal of this observational study is to learn about the prevalence and characteristics of functional gastrointestinal disorders (FGID) in at risk infants (former preterm infants and those with birth asphyxia) during the first 2 years of life. The main questions it aims to answer are: * evaluate the prevalence of symptoms related to gastro-esophageal reflux (GER), of functional gastrointestinal disorders during the first 2 years of life * describe growth parameters during follow-up up to the corrected age of 2 years Participants will be assessed clinically and with a structured questionnaire based on the Rome IV criteria to describe FGID.

Who can participate

Age range3 Months – 24 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * infants with gestational age at birth \< 31 weeks * infants with gestational age at birth \< 37 weeks and major respiratory or neurologic morbidity * infants with history of perinatal asphyxia Exclusion Criteria: * lack of informed consent * diagnosis of congenital or other major gastrointestinal disease (i.e. inflammatory bowel disease, cancer)

What they're measuring

Prevalence of FGID

Timeframe: 3, 6, 12, 24 months of corrected age

Frequency of FGID

Timeframe: 3, 6, 12, 24 months of corrected age

Severity of FGID

Timeframe: 3, 6, 12, 24 months of corrected age

Trial details

NCT IDNCT06031025

SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-09-30

Contact for this trial

Stefano Nobile, MD, PhD, MSc

+390630156937 stefano.nobile@policlinicogemelli.it

View on ClinicalTrials.gov More Functional Gastrointestinal Disorders trials